Latest Insights

Artificial Intelligence

Why 93% of Companies Are Implementing AI but Only 33% of Employees Know About It

93% of companies implement AI, but only 33% of employees know. The gap isn’t technology—it’s how organizations manage change.

Regulatory Affairs

FDA’s Quality Management System Regulation (QMSR) Final Rule

The FDA QMSR Final Rule aligns 21 CFR 820 with ISO 13485:2016. Learn what changes and how medical device manufacturers should prepare.

Veterinary

Are Your Veterinary Pharmaceutical Operations Ready for Commission Implementing Regulation EU 2025/2091 and 2025/2154?

Commission Implementing Regulations (EU) 2025/2091 and 2025/2154 will make GMP compliance legally binding for veterinary medicinal products.

GxP Compliance

Quality by Design in an Era of Advanced Technologies in Life Sciences

Quality by Design (QbD): building quality from the start with QTPP, CQAs, and CPPs—now powered by AI, ML, and Digital Twins to transform Life.

GxP Compliance

EU GMP Annex 11 Ch.4 & Annex 22: Latest EU regulatory updates

From data integrity to AI: the new EU GMP guidelines set a higher standard for compliance in the life sciences industry.

GxP Compliance

Pharma On The Road To Sustainability: Compliance & New Regulations

Pharma faces new regulations driving eco-friendly practices and ESG compliance for a sustainable future.

Medical Device

Why Your Software as a Medical Device (SaMD) Development Should Take a Quality by Design Approach 

Learn why Software as a Medical Device development needs a Quality by Design approach to ensure safety, compliance, and patient trust

CSV & Data Integrity

PQE Group and Data Integrity Assessment: The First Step Towards Total Compliance

CSA: the future of validation in life sciences—smart, risk-based, and patient-focused

FemTech

Breast Cancer Awareness Month: FemTech and Innovation in the Global Fight Against Breast Cancer

Discover how FemTech and AI are reshaping the global fight against breast cancer. PQE Group drives innovation and awareness.

FemTech

Meet the Online Communities Writing the Future of FemTech and Women's Health

Discover how online communities are reshaping FemTech, empowering women, and redefining the future of women’s health